Altaire Pharmaceuticals Recalls ActivEyes Altachlore Solution for Sterility Concerns
Altaire Pharmaceuticals is recalling ActivEyes Altachlore Solution due to a lack of assurance of sterility. The recall covers 22,494 units distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterility issues in ophthalmic products which carry significant risk of infection.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling ActivEyes Altachlore Solution, 15 mL (1/2 FL OZ), NDC 59390-183-13. The recall is being conducted due to a lack of assurance of sterility. The affected product is an ophthalmic solution manufactured by Altaire Pharmaceuticals Inc. in Aquebogue, NY.
A total of 22,494 units are subject to this recall. The distribution pattern is listed as U.S.A. Nationwide. Specific lot codes identified in the recall include 18008, 19050, and 19105, with associated expiration dates ranging from 2018 to 2019.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ALTACHLORE SODIUM CHLORIDE HYPERTONICITY (SODIUM CHLORIDE)
- Brand
- ALTACHLORE SODIUM CHLORIDE HYPERTONICITY
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 22,494
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 18008 1/20 8/13/2018 19050 2/22 3/18/2019 19105 4/22
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 134 recalled by Altaire Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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